FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OmniPore DUROMAX Surgical Implants
K Number: K180249
·
Decision Oct 11, 2018
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
2
Review Days
255
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Basic Information
- Device Name
- OmniPore DUROMAX Surgical Implants
- K Number
- K180249
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Matrix Surgical Holdings, LLC/Matrix Surgical USA
- Date Received
- January 29, 2018
- Decision Date
- October 11, 2018
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by Matrix Surgical Holdings, LLC/Matrix Surgical USA
| K Number | Device Name | ||
|---|---|---|---|
| K133046 | OMNIPORE CUSTOMIZED SURGICAL IMPLANTS | May 14, 2014 | Substantially Equivalent |